Gallus BioPharmaceuticals, LLC has acquired Laureate Biopharmaceutical Services, Inc., a full service biologics CMO based in Princeton, NJ, doubling its process development (PD) and clinical drug substance manufacturing capacity, adding full protein characterization, and testing and clinical fill-finish capability. Financial details were not disclosed.
The combined organizations offer two Centers of Excellence for manufacturing therapeutic proteins using mammalian cell-culture: the Princeton site for PD solutions and manufacture of clinical-stage products, including fill-finish, and the St. Louis site for PD, clinical and commercial manufacture of biopharmaceutical products. Both sites are FDA approved, and the St. Louis site is licensed by all major global regulatory authorities. The combined team includes 350 experienced staff. Gallus now has multiple clinical and commercial suites at the two sites, with 50L to 2,000L GMP single-use platforms from Xcellerex and HyClone in addition to 50L to 2,000L fixed and flexible stainless steel bioreactors and associated downstream purification for drug substance.
Michael A. Griffith, Laureate chief executive officer, who will support the transition for several months, said, "The merger of Laureate into Gallus benefits our clients and our employees by creating a more secure and diverse platform including important additional technologies and capabilities. Our client portfolio includes late-stage clinical programs advancing towards launch that will immediately benefit from the commercial readiness of the Gallus St. Louis site. Importantly, we believe that the service mindsets of Gallus and Laureate are well matched."
Mark R. Bamforth, Gallus president and chief executive officer, said, “This acquisition is another important step towards realizing Gallus’ vision to be the most trusted provider of world class biologics manufacturing and development services for the pharmaceutical and biotechnology industry. By combining Laureate and Gallus, we double the development and clinical capacity of Gallus with a uniquely flexible combination of stainless steel and single use technologies and capacities to suit every client’s process needs. Critically, we have an established, reliable commercial pathway for late stage molecules and expect to continue to grow our organization and make further capital investments to serve client needs.”